TranS1® - The Least Invasive Solution to Lumbar Fusion
 

For Surgeons AxiaLIF®: Indications, Contraindications, and Warnings

CAUTION: Rx Only

INDICATIONS: TranS1 AxiaLIF® System is intended to provide anterior stabilization of the L5-S1 spinal segment as an adjunct to spinal fusion. The AxiaLIF® System is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion) spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF® System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy, or for assistance in the performance of L5-S1 interbody fusion. The AxiaLIF® System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor, or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 in conjunction with legally marketed posterior fixation systems.

CONTRAINDICATIONS: Coagulopathy; Bowel disease (e.g. Crohn's, Ulcerative Colitis); Pregnancy; Severe scoliosis; Sacral agenesis; Severe spondylolisthesis (>grade 2); Tumor; Trauma; Do not use with facet screws when correction of spinal stenosis requires removal of significant portions of the lamina or any portion of the facets.

WARNINGS: The risks to the patients are similar to those for patients undergoing any spine stabilization surgery. The most frequently stated risks are bleeding (including occult during and after surgery), neurological damage, damage to soft tissue, spinal cord impingement or damage, infection, loss of bowel or bladder function, loss of erectile or ejaculatory function, meningitis, or pain. Pedicle screw systems, not facet screws, should be considered when there is degenerative disease of the facets with instability. The risks associated with the implant include: breakage of the implants, loosening or expulsion of the implants possibly causing delayed nerve root impingement or damage, fracture of osseous structures, and bursitis. There may be pain, discomfort or abnormal sensations due to the presence of the device. There may be risks associated with harvesting autologous grafts such as pain at the donor site, infection, herniation, and fracture. There may be nonunion or delayed union of fusion with the autologous graft. The safety and effectiveness of this device has not been evaluated in patients with spondylolysis. Pedicle screw systems, not facet screws, should be considered when there is degenerative disease of the facets with instability. The safety and effectiveness of this device has not been evaluated in patients with transitional vertebrae or additional vertebrae (i.e. L6).

PRECAUTIONS:

  • Preoperative: Portions of this system are supplied non-sterile and need to be cleaned and sterilized according to the CLEANING AND STERILIZATION section of this insert. Care should be taken during the pre-operative preparation to evaluate the ability to achieve a desirable implant trajectory. Severe angulation of the vertebral bodies may make achievement of an effective trajectory difficult. Preoperative planning should include identification of any pre-existing adhesions of the bowel to the sacrum. A bowel perforation could occur during creation of the presacral channel if there is an adhesion of the bowel to the sacrum.

Physicians using the TranS1® AxiaLIF® System should have significant experience in spinal surgery, including spinal fusion procedures. Physicians should not independently use the AxiaLIF® System prior to participation in specific training on its use.

  • Intraoperative: All steps of the procedure should be followed as per the "Surgical Technique". All steps in this technique require the use of active or real time fluoroscopy. Refer to "Surgical Technique" for proper 3D Axial Rod™ sizing.
  • Postoperative: Risk of occult bleeding exists during and after the procedure. As with all surgical procedures, careful patient monitoring is required to minimize this risk. Following the procedure the patient should be monitored until released for any effects of the procedure. The patient should adhere to post-operative instructions as provided by physician.
TranS1® - The Least Invasive Solution to Lumbar Fusion